S-0179.4  _______________________________________________


                         SENATE BILL 5494



State of Washington      55th Legislature     1997 Regular Session


By Senators Deccio, Wojahn, Fairley, Wood and Prentice


Read first time 01/28/97.  Referred to Committee on Health & Long‑Term Care.

Regulating clinical laboratory science practitioners.

    AN ACT Relating to clinical laboratory science practitioners; reenacting and amending RCW 18.130.040; adding a new chapter to Title 18 RCW; and providing an effective date.




    NEW SECTION.  Sec. 1.  The legislature finds that it is necessary to regulate the practice of clinical laboratory science in order to protect the public health, safety, and welfare.  It is the intent of the legislature that this chapter provide for better protection of public health and safety by providing minimum qualifications for clinical laboratory science practitioners, thereby increasing the degree of professional competence of persons performing laboratory tests.


    NEW SECTION.  Sec. 2.  Unless the context clearly requires otherwise, the definitions in this section apply throughout this chapter.

    (1) "Clinical laboratory" or "laboratory" means a facility, office, or site where clinical laboratory tests are performed.

    (2) "Clinical laboratory science" means the use of the following scientific disciplines to assess, examine, and analyze biological specimens:  Biochemistry, chemistry, immunology, immunohematology, hematology, serology, virology, microbiology, parasitology, cytology, histology, radioimmunology, phlebotomy, microscopy, or other related fields.

    (3) "Clinical laboratory science scope of practice" means the performance of clinical laboratory tests and related activities, including all phases of test performance from procurement of specimens to reporting of results; collection of specimens, including blood specimens using venous, arterial, or capillary puncture; performance of minor, invasive procedures for diagnostic purposes; and training others to perform phlebotomy.  "Clinical laboratory science scope of practice" includes assessing specimens for adequacy and appropriateness; calibrating and maintaining instruments; verifying quality control; detecting, assessing, and correcting malfunctions, failures, and other problems; judging the results to be reasonable and acceptable using other known information and correlation with other results; reporting and consulting on laboratory results; and providing consultation on interpretation of laboratory test methods.  These activities are to be performed during the preanalytical, analytical, and postanalytical phases of clinical laboratory testing.

    (4) "Clinical laboratory science practitioner" means a person licensed under this chapter to perform clinical laboratory science scope of practice.

    (5) "Clinical laboratory test" or "laboratory test" means a microbiological, serological, chemical, hematological, radiobioassay, cytological, biophysical, immunological, or other pathological examination that is performed on material derived from the human body, or any other such test or procedure that provides information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition, including screening.

    (6) "Committee" means the clinical laboratory practice advisory committee established under section 5 of this act.

    (7) "Department" means the department of health.

    (8) "Limited laboratory testing" means laboratory testing, specimen collection, and performance of limited, minor, invasive procedures for diagnostic purposes authorized by the secretary by rule to be performed by registered laboratory testing assistants.

    (9) "Registered laboratory testing assistant" means a person registered under this chapter to perform limited laboratory testing.

    (10) "Secretary" means the secretary of the department of health.


    NEW SECTION.  Sec. 3.  This chapter does not apply to:

    (1) Any person licensed in this state who, under any other licensing authority, engages in the practice for which he or she is licensed or certified;

    (2) A clinical laboratory science practitioner employed by the United States government or any bureau, division, or agency of the United States while in the discharge of the employee's official duties;

    (3) A clinical laboratory science practitioner engaged in teaching or research if the results of the examination performed are not used in health maintenance, screening, or diagnosis or treatment of disease;

    (4) A student or trainee enrolled in a clinical laboratory science education program, if the activities constitute a part of a planned course in the program, the person is designated by a title such as intern, trainee, or student, and the person works directly under an individual licensed by this state to perform clinical laboratory science scope of practice or an instructor exempt under subsection (3) of this section;

    (5) A business manager of a laboratory if the person has no direct involvement with test performance;

    (6) Other persons, as defined in rule by the secretary, who are determined not intended to be covered by this chapter.


    NEW SECTION.  Sec. 4.  (1) No person may perform clinical laboratory science scope of practice or hold himself or herself out as a clinical laboratory science practitioner, or like term, in this state unless the person is licensed under this chapter.

    (2) No person may perform limited laboratory testing or hold himself or herself out as a registered laboratory testing assistant, or like term, unless the person is registered or licensed under this chapter.


    NEW SECTION.  Sec. 5.  The secretary shall appoint a clinical laboratory practice advisory committee of eight persons; of whom four are experienced and knowledgeable clinical laboratory science practitioners, two are clinical laboratory science educators, and two are public members.  The committee shall advise the department on professional and technical matters pertaining to the implementation and administration of this chapter.

    (1) Public members of the committee may not be members of any other health care licensing board or commission, have a fiduciary obligation to a clinical laboratory, or have a material or financial interest in the rendering of health services regulated by the committee.

    (2) Members of the committee must be compensated in accordance with RCW 43.03.240 and are entitled to travel expenses in accordance with RCW 43.03.050 and 43.03.060.

    (3) Members of the committee shall serve three-year terms.  Of the initial members, two must be appointed to one-year terms, three must be appointed to two-year terms, and three must be appointed for three-year terms.  Thereafter, members must be appointed for three-year terms.  The member shall not serve more than two full terms.


    NEW SECTION.  Sec. 6.  With the advice of the committee, the secretary shall:

    (1) Delineate education and training qualifications for licensure of clinical laboratory science practitioners and registration of laboratory testing assistants with consideration of the complexity and risk of harm of the tests allowed by the license or registration and of reciprocity with other states and licensing authorities;

    (2) Specify requirements for the renewal of licensure or registration;

    (3) Approve accrediting and certification bodies for purposes of licensure of clinical laboratory science practitioners;

    (4) Establish qualifications for licensure of specialists in such clinical laboratory science specialities as the secretary may determine;

    (5) Establish limited types of laboratory testing and limited specimen collection that may be performed by registered laboratory testing assistants;

    (6) Establish criteria for the continuing competency of persons regulated under this chapter as required for license or registration renewal;

    (7) Adopt rules, policies, procedures, and requirements as appropriate to carry out the purpose of this chapter;

    (8) Set administrative procedures, administrative requirements, and fees in accordance with RCW 43.70.250 and 43.70.280.  All fees collected under this section must be credited to the health professions account as required under RCW 43.70.320; and

    (9) Hire additional staff as necessary in order to implement the provisions of this chapter.


    NEW SECTION.  Sec. 7.  The uniform disciplinary act, chapter 18.130 RCW, governs unlicensed or unregistered practice, the issuance and denial of licenses and registrations, and the discipline of persons licensed or registered under this chapter.


    Sec. 8.  RCW 18.130.040 and 1996 c 200 s 32 and 1996 c 81 s 5 are each reenacted and amended to read as follows:

    (1) This chapter applies only to the secretary and the boards and commissions having jurisdiction in relation to the professions licensed under the chapters specified in this section.  This chapter does not apply to any business or profession not licensed under the chapters specified in this section.

    (2)(a) The secretary has authority under this chapter in relation to the following professions:

    (i) Dispensing opticians licensed under chapter 18.34 RCW;

    (ii) Naturopaths licensed under chapter 18.36A RCW;

    (iii) Midwives licensed under chapter 18.50 RCW;

    (iv) Ocularists licensed under chapter 18.55 RCW;

    (v) Massage operators and businesses licensed under chapter 18.108 RCW;

    (vi) Dental hygienists licensed under chapter 18.29 RCW;

    (vii) Acupuncturists licensed under chapter 18.06 RCW;

    (viii) Radiologic technologists certified and X-ray technicians registered under chapter 18.84 RCW;

    (ix) Respiratory care practitioners certified under chapter 18.89 RCW;

    (x) Persons registered or certified under chapter 18.19 RCW;

    (xi) Persons registered as nursing pool operators under chapter 18.52C RCW;

    (xii) Nursing assistants registered or certified under chapter 18.79 RCW;

    (xiii) Health care assistants certified under chapter 18.135 RCW;

    (xiv) Dietitians and nutritionists certified under chapter 18.138 RCW;

    (xv) Sex offender treatment providers certified under chapter 18.155 RCW;

    (xvi) Persons licensed and certified under chapter 18.73 RCW or RCW 18.71.205;

    (xvii) Persons registered as adult family home providers and resident managers under RCW 18.48.020; ((and))

    (xviii) Denturists licensed under chapter 18.30 RCW; and

    (xix) Persons licensed or registered under chapter 18.-- RCW (sections 1 through 7, 9, and 10 of this act).

    (b) The boards and commissions having authority under this chapter are as follows:

    (i) The podiatric medical board as established in chapter 18.22 RCW;

    (ii) The chiropractic quality assurance commission as established in chapter 18.25 RCW;

    (iii) The dental quality assurance commission as established in chapter 18.32 RCW;

    (iv) The board of hearing and speech as established in chapter 18.35 RCW;

    (v) The board of examiners for nursing home administrators as established in chapter 18.52 RCW;

    (vi) The optometry board as established in chapter 18.54 RCW governing licenses issued under chapter 18.53 RCW;

    (vii) The board of osteopathic medicine and surgery as established in chapter 18.57 RCW governing licenses issued under chapters 18.57 and 18.57A RCW;

    (viii) The board of pharmacy as established in chapter 18.64 RCW governing licenses issued under chapters 18.64 and 18.64A RCW;

    (ix) The medical quality assurance commission as established in chapter 18.71 RCW governing licenses and registrations issued under chapters 18.71 and 18.71A RCW;

    (x) The board of physical therapy as established in chapter 18.74 RCW;

    (xi) The board of occupational therapy practice as established in chapter 18.59 RCW;

    (xii) The nursing care quality assurance commission as established in chapter 18.79 RCW governing licenses issued under that chapter;

    (xiii) The examining board of psychology and its disciplinary committee as established in chapter 18.83 RCW; and

    (xiv) The veterinary board of governors as established in chapter 18.92 RCW.

    (3) In addition to the authority to discipline license holders, the disciplining authority has the authority to grant or deny licenses based on the conditions and criteria established in this chapter and the chapters specified in subsection (2) of this section.  This chapter also governs any investigation, hearing, or proceeding relating to denial of licensure or issuance of a license conditioned on the applicant's compliance with an order entered pursuant to RCW 18.130.160 by the disciplining authority.

    (4) All disciplining authorities shall adopt procedures to ensure substantially consistent application of this chapter, the Uniform Disciplinary Act, among the disciplining authorities listed in subsection (2) of this section.


    NEW SECTION.  Sec. 9.  If any provision of this act or its application to any person or circumstance is held invalid, the remainder of the act or the application of the provision to other persons or circumstances is not affected.


    NEW SECTION.  Sec. 10.  This chapter may be cited as the clinical laboratory science practice act.


    NEW SECTION.  Sec. 11.  Sections 1 through 4, 7, and 8 of this act take effect July 1, 1998.


    NEW SECTION.  Sec. 12.  Sections 1 through 7, 9, and 10 of this act constitute a new chapter in Title 18 RCW.


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